ETHICON LLC

Patent Trials and Appeals Board

Dec 14, 2021

2021003561 (P.T.A.B. Dec. 14, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/692,342 08/31/2017 Mark A. Davison END8249USNP.0649755 3267 135715 7590 12/14/2021 Cilag GmbH International c/o Frost Brown Todd LLC 3300 Great American Tower 301 East Fourth Street Cincinnati, OH 45202 EXAMINER AVIGAN, ADAM JOSEPH ART UNIT PAPER NUMBER 3794 NOTIFICATION DATE DELIVERY MODE 12/14/2021 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): jdewar@fbtlaw.com patents@fbtlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MARK A. DAVISON, MARK E. TEBBE, KRISTEN G. DENZINGER, RYAN M. ASHER, CRAIG T. DAVIS, KEVIN BASH, ERIC ROBERSON, JOHN E. BRADY, JEFFREY A. BULLOCK, JEFFREY L. ALDRIDGE, MONICA L. ZECKEL, SHAN WAN, and KRISTEN L. D'UVA Appeal 2021-003561 Application 15/692,342 Technology Center 3700 Before STEFAN STAICOVICI, CHARLES N. GREENHUT, and JEREMY M. PLENZLER, Administrative Patent Judges. GREENHUT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 9, 10, 20-25, and 31. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Ethicon LLC a subsidiary of Johnson & Johnson. Appeal Br. 3. Appeal 2021-003561 Application 15/692,342 2 We AFFIRM IN PART. CLAIMED SUBJECT MATTER The claims are directed to an end effector for electrosurgical instrument with irrigation. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. An apparatus, comprising: (a) a shaft assembly, wherein the shaft assembly comprises: (i) an outer sheath having a distal end, (ii) at least one irrigation conduit extending through the outer sheath, wherein the at least one irrigation conduit is configured to couple with a source of an irrigation fluid, and (iii) at least one suction conduit extending through the outer sheath, wherein the at least one suction conduit is configured to couple with a source of suction; and (b) an end effector, wherein the end effector comprises: (i) a first electrode extending distally relative to the distal end of the outer sheath, (ii) a second electrode extending distally relative to the distal end of the outer sheath, wherein the first and second electrodes are operable to apply bipolar RF energy to tissue, and (iii) a web extending laterally between the first and second electrodes, wherein the web is positioned distal to the distal end of the outer sheath, wherein the web is fluidly coupled with the at least one irrigation conduit and configured to receive the irrigation fluid therefrom, wherein the web is selectively operable to discharge the irrigation fluid from the irrigation conduit through a surface of the web. Appeal 2021-003561 Application 15/692,342 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Lu US 7,749,222 B2 July 6, 2010 Lipson US 2007/0016182 A1 Jan. 18, 2007 Greeley US 2011/0125146 A1 May 26, 2011 REJECTIONS Claims 1, 9, 20-24, and 31 are rejected under 35 U.S.C. § 103 as being unpatentable over Greeley and Lipson. Final Act. 3. Claims 10 and 25 are rejected under 35 U.S.C. § 103 as being unpatentable over Greeley, Lipson, and Lu. Final Act. 8. OPINION Claims 1, 9, 10, 20, and 21 Background The issues raised in this appeal concerning independent claims 1 and 20 relate to limitation (b)(iii) reproduced above. Though argued under separate subheadings, the issues raised by Appellant concerning claims 1 and 20 are substantially the same. The Examiner finds in Greeley “a web associated with the first and second electrodes, wherein the web is positioned distal to the distal end of the outer sheath (Fig. 45 and par. 23, ‘fluid couplings 524a, 524b comprise discrete, localized webs’).” Final Act. 3. Recognizing the couplings regarded as Greeley’s webs fail to “extend[] laterally” between the electrodes the Examiner cites “Lipson [which] teaches an alternative configuration in which the web extends laterally between the first and second electrodes forming a conductive bridge between the first and second electrodes (Fig. 43).” The Examiner points out that Lipson expressly states the benefits Appeal 2021-003561 Application 15/692,342 4 associated with extending the couplings 30a, 30b, regarded by the Examiner as the recited “web” between the electrodes-to form a shunt-and this reasoning in support of the Examiner’s proposed modification to Greeley’s device is not challenged by Appellant. Final Act. 4: Lipson para. 252. Instead, Appellant argues that neither Greeley’s nor Lipson’s couplings (524a, 524b; 30a, 30b; respectively) can reasonably be regarded as a “web” according to claims 1 and 20. Appeal Br. 12-16. Beginning first with the meaning of the term “web,” itself, Appellant’s Specification discloses various arrangements of webs (330, 430, 530, 630, 650, 670). See, e.g., Figs. 28-36. In these examples, Appellant is using the term “web” to refer to “A thin flat part connecting thicker or more solid parts in machinery.”2 Greeley and Lipson are commonly assigned,3 and employ very similar terminology to describe their respective fluid couplings. Greeley states: As shown in FIG. 45, fluid couplings 524a, 524b comprise discrete, localized webs and more specifically comprise triangular shaped webs or bead portions providing a film of fluid 502 between surface 522 of tissue 520 and electrodes 180a, 180b. Greeley para. 203 (emphasis added). Lipson states: Fluid couplings 30a, 30b preferably comprising discrete, localized webs and more preferably comprising a triangular 2 https://www.lexico.com/en/definition/web last accessed Nov. 24, 2021. 3See https://assignment.uspto.gov/patent/index.html#/patent/search/resultAbstract ?id=12877400&type=applNum and https://assignment.uspto.gov/patent/index.html#/patent/search/resultAbstract ?id=10547881&type=applNum last accessed Nov. 24, 2021. Appeal 2021-003561 Application 15/692,342 5 shaped web or bead portion providing a film of fluid 24 between surface 22 of tissue 32 and electrodes 25a, 25a. Lipson para. 250 (emphasis added). It is noted that, like the Examiner, at times we make reference to Lipson’s description of Figure 42 even though the Examiner relied upon the embodiment depicted in Figure 43 of Lipson because Lipson provides more details in the discussion of Figure 42. Lipson indicates that the embodiment depicted in Figure 43 is like that depicted in Figure 42 but “with an alternative fluid coupling to a tissue surface.” Lipson para. 58. That alternative fluid coupling permits diversion of RF energy via a conductive fluid bridge 27 (illustrated but not labeled in Figure 43) forming a shunt between the electrodes 25a, 25b. Neither Greeley nor Lipson provides further detail regarding the makeup of the “discrete, localized webs.” According to the Examiner, dictionary evidence suggests that Greeley and Lipson are using the term “web” to refer to “‘Woven fabric, cloth. Also: a piece of woven fabric; a piece of fabric in the process of being woven.’” Ans. 5 (citing Oxford English Dictionary). Appellant, on the other hand, believes that Greeley and Lipson’s mention of “triangular shaped web[s] or bead portions” is intended to refer to the shape of the fluid being dispersed from the respective outlets and thus refers to the fluid itself as opposed to some structure for carrying it. Appeal Br. 12-16; Reply Br. 8-11. If Appellant’s interpretation of Greeley and Lipson is correct, there is no dispute that the cited fluid couplings would not meet the claim language for several reasons, including, as Appellant correctly points out, because the fluid itself under the broadest reasonable interpretation cannot be “configured to receive” and “operable to discharge” (claim 1) or “disperse [by its surface]” (claim 20) itself. Appeal Br. 12-16. Appeal 2021-003561 Application 15/692,342 6 Analysis Initially, we note that we are mindful of the distinction between the way the term “web” is used according to Appellant’s Specification and the dictionary definition provided by the Examiner. It is well settled that identical language need not be used by a prior art reference being applied by the Examiner in the context of an anticipation or obviousness analysis to demonstrate that the prior art reference discloses subject matter falling within the scope of a claim limitation. In that same vein, the use of identical language does not necessarily mean the subject matter of the prior art falls within the scope of that language as it is used in a claim being analyzed. Ultimately, it is the meaning of the words that must be explored. In re Neugebauer, 330 F.2d 353, 356 n. 4 (CCPA 1964) (“In the construction of words, not the mere words, but the thing and the meaning, are to be inquired after.”). Regardless of the differences in asserted definitions of the term “web,” the Examiner’s proposed modification results in something relatively “thin [and] flat” that is “connecting thicker or more solid parts in machinery” consistent with the definition of web discussed that is most consistent with Appellant’s Specification as discussed above. This is because the Examiner’s proposed modification to Greeley’s teachings incorporates Lipson’s fluid couplings, illustrated in the embodiment depicted in Figure 43 of Lipson, which extend laterally between Lipson’s electrodes. Final Act. 4.. Appellant does not advance any arguments to the contrary. Thus, as correctly characterized by the Examiner, the issue boils down to whether the cited fluid couplings comprising webs can reasonably be considered a structural “part” or are instead only formed by the fluid. Ans. 4. On the record presently before us, the Examiner has the better position on Appeal 2021-003561 Application 15/692,342 7 this point. The Examiner is the only one to enter any evidence to show what seems to be a suitable and appropriate meaning for the term “web” as referring to a piece of fabric, i.e., a structural part. Ans. 5. We agree that the term “web” can also be used by a skilled artisan to mean “[a] latticed or woven structure” or “[a] complex, interconnected structure or arrangement.”4 Such construction of the term “web” is also consistent with Appellant’s Specification, which describes a “web” as “an electrically non- conductive material.” Spec. para. 66 (emphasis added). For example, a porous fabric would seem well suited for directing fluid toward tissue as well as providing the shunting capability described in paragraph 252 of Lipson. Appellant does not offer evidence to show instances where in this art, or colloquially, the term “web” is ever used to refer to a structure formed by fluid itself. In particular, Appellant does not adequately explain how Lipson’s saline solution could be considered a “web,” by a skilled artisan, of the types mentioned above or otherwise. See Lipson, paras. 80, 91. Appellant is also in the best position to furnish additional evidence concerning the details of the actual devices discussed in Greeley and Lipson and has not done so. The evidence presently before us may not demonstrate with absolute certainty that the fluid couplings comprising webs are specifically fabrics as the Examiner asserts. Nonetheless, the weight of evidence presently before us favors the Examiner’s conclusion that the “webs” in Greeley and Lipson are at the very least some sort of structural “part,” if not some sort of fabric part, and are not comprised entirely of the fluid itself as Appellant argues. Moreover, the use of the term “discrete” in the phrase “discrete, localized webs” implies that the webs of Greeley and 4 The Free Dictionary, https://www.thefreedictionary.com/web. Appeal 2021-003561 Application 15/692,342 8 Lipson constitute a separate entity, that is, a separate structure. See Greeley para. 203; Lipson para. 250. With this understanding of Greeley and Lipson, Appellant’s only remaining argument is that Greeley’s couplings 524a, 524b, as modified according to Lipson’s teachings, still would not “discharge the irrigation fluid from the irrigation conduit through a surface of the web.” Reply Br. 8. Though not entirely clear from Appellant’s remarks, we understand Appellant to arrive at this conclusion because Greeley depicts droplets 526a, 526b forming at circumferentially arranged fluid outlets 208a/210a/212a/214a and 208b/210b/212b/214b longitudinally (vertically in Figure 45) spaced from fluid couplings 524a, 524b. Reply Br. 8 (annotating Greeley Fig. 45). However, the ability of the web to “discharge the irrigation fluid from the irrigation conduit through a surface of the web” does not require any direct fluidic connection between the conduit outlet and the web. In other words, the claim language does not preclude an arrangement wherein fluid 502 is communicated from the conduit outlets to the web via the electrodes or via gravity or other forces: Fluid 502 is expelled from fluid outlets 208a/210a/212a/214a and 208b/210b/212b/214b around the surfaces of electrodes 180a, 180b and onto the surface 522 of the tissue 520 via couplings 524a, 524b. For the foregoing reasons, we sustain the Examiner’s rejection of claims 1 and 20 as well as the rejections of the claims depending therefrom. Appeal 2021-003561 Application 15/692,342 9 Claims 22-25 and 31 In addition to the arguments discussed above, Appellant advances the additional argument regarding claim 22 that Greeley’s fluidic couplings are not “removably coupled” with Greeley’s end effector. The Examiner initially takes the position that “the fluid coupling device is innately removable from the end effector” in Greeley. Final Act. 6. However, it is well-settled that when relying on a theory of inherency it is incumbent upon the Examiner to furnish sufficient evidence and reasoning to establish a sound basis for the belief that the supposedly inherent subject matter is necessarily present in the prior art. MPEP § 2112(IV). This has not been done by the Examiner. In the Answer, the Examiner states: Even if for the sake of argument, it were accepted the web were fixedly attached to the end effector, it is the examiner’s position that the web would still be capable of being removed from the end effector in one way or another, e.g. using scissors. Ans. 11. We must determine whether, in this context, “removably coupled” includes being coupled in such a way that destruction of the coupling is required for removal. Interpreting claims in light of the Specification means that the Specification provides the best guidance as to delineating situations where such an interpretation is reasonable and when it is not. The challenge is to interpret the meaning of claim terms without importing unrecited limitations into the claims. In re Prater, 415 F.2d 1393, 1404-05 (CCPA 1969). Here, the Examiner does not direct our attention to any exemplary embodiments in the Specification where the coupling structure for the web is Appeal 2021-003561 Application 15/692,342 10 sacrificed or otherwise destroyed to effect the web’s removal. In contrast, Appellant directs our attention to the embodiment depicted in Figure 35 where openings 754, 756 having snap arms 758 are used to secure cartridge 750 carrying sponge member 770 (“web”) and allow it to be “simply remove[d].” Spec. paras. 77-79. Although once detached, the language of claim 22 does not necessarily require the ability of the web to be “re- attached” as Appellant suggests (Appeal Br. 11), the Examiner does not provide sufficient evidence or reasoning to support the conclusion that in the context of Appellant’s Specification, which only appears to use the term “removably” to refer to non-destructive removal, one skilled in the art would understand “removably coupled” to include a web that could be cut off with scissors. Allowing destructive removal in this context would effectively read the term “removably” out of the claim, as virtually any two items can be separated by destructive means. Further, little is known of the mechanism and manner by which Greeley’s fluidic couplings are attached to the end effector so very little can be deduced about how easily they can be removed with scissors or otherwise. For the foregoing reasons, we do not sustain the Examiner’s rejection of claim 22 and, as the Examiner does not apply Lu in a manner to cure this deficiency, the rejections of those claims depending therefrom. CONCLUSION The Examiner’s decision to reject claims 1, 9, 10, 20, and 21 is AFFIRMED. The Examiner’s decision to reject claims 22-25 and 31 is REVERSED. Appeal 2021-003561 Application 15/692,342 11 DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 9, 20-24, 31 103 Greeley, Lipson 1, 9, 20, 21 22-24, 31 10, 25 103 Greeley, Lipson, Lu 10 25 Overall Outcome 1, 9, 10, 20, 21 22-25, 31 RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED IN PART